The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA).

The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study. Up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.

Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month post-stent removal.

Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]

Stent lumen patency at 30 days and/or 60 days.

Effectiveness: Stent Removability at 30 Days and/or 60 Days [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]

AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.

Effectiveness: Technical Success [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]

Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.

Clinical Success [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]

Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.

The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.

Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.

To demonstrate the safety and effectiveness of the Xlumena AXIOS Stent and Delivery System for endoscopic drainage of pancreatic pseudocysts in patients with symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm (≥6cm) in diameter, have ≥ 70% fluid contents and are adherent to the bowel wall.

Technical success, defined as: placement of the AXIOS stent using the AXIOS delivery system and removal of the AXIOS stent using a standard endoscopic snare.

Clinical success, defined as: at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.

PATIENT POPULATION:

Patients between 18 and 75 years of age, suitable for transluminal drainage of symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm in diameter and adherent to the bowel wall are candidates for study treatment.

The target enrollment for the study is 24 subjects. Study will be conducted at up to 10 investigational sites in the United States, Japan and/or the European Community. A majority of the patients will be enrolled in the United States.

Symptomatic pancreatic pseudocyst having the following characteristics:

Greater than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan),

Adherent to bowel wall, and

≥70% fluid content

Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.

Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion Criteria:

(patients meeting any of the below criteria will be excluded from study)

<18 or >75 years of age

Pancreatic pseudocysts having the following characteristics:

Require nasocystic drainage,

< 69% fluid content

The fluid collection to be drained is an immature pseudocyst

The fluid collection to be drained is a cystic neoplasm

The fluid collection to be drained is a pseudoaneurysm

The fluid collection to be drained is a duplication cyst

The fluid collection to be drained is a non-inflammatory fluid collection

There is more than one pseudocyst requiring drainage

Abnormal coagulation:

INR > 1.5 and not correctable

presence of a bleeding disorder

platelets < 50,000/mm3

Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).

Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)

Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.

Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.

Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419769